Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:56 PM
Ignite Modification Date:
2025-12-24 @ 5:56 PM
NCT ID:
NCT02389868
Eligibility Criteria:
Inclusion Criteria:
* Being an individual age 18 to 40.
* If applicable, female participants susceptible of becoming pregnant consent to use a highly efficient contraception technique AND an efficient contraception technique during the clinical trial and at least 3 months following ending the consumption of Lovastatin.
* Being able to read and understand French.
Exclusion Criteria:
* Having a known history of dyslipidemia.
* In regard of the lipid profile at the first visit, patients that are not comprised between the 5th and the 95th percentile for LDL, HDL or Total cholesterol will be excluded.
* Having a history of hypersensitivity to Lovastatin, to one of the components of this product or to any other statin.
* Being affected by mental retardation.
* Pregnancy or suspicion of pregnancy.
* Having an excessive alcohol consumption (a maximum of 3 drinks a day during the trial will be accepted).
* Planning to perform unusual and very intense physical exercises during the study (ex: running a marathon or an Iron Man).
* Having a history of myopathy, myalgia or elevated creatine kinase (CK).
* In regard of the biochemical tests performed at the first visit, individuals having CK levels three times (or more) superior to the upper normal limit will be excluded.
* Having a personal or family history of hereditary muscular diseases.
* Having a history of renal or hepatic pathology.
* Taking one of the following drugs : any hypolipemic drug, any cytochrome P450 isoform 3A4 inhibitor (itraconazole, ketoconazole, posaconazole, voriconazole, HIV protease inhibitors, boceprevir, erythromycin, clarithromycin, telithromycin, nefazodone and products containing cobicistat), ACE inhibitors, danazol, verapamil, diltiazem, cyclosporin, amiodarone, colchicine, fusidic acid (IV or oral).
* Having a history of hypothyroidism.
* Having had a surgical intervention shortly before the beginning of the clinical trial.
* Suffering from any other acute medical condition.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT02389868
Study Brief:
Protocol Section:
NCT02389868